- NEW
- 常勤
- 兵庫県
【兵庫県】MD求人
Senior Clinical Pharmacology Lead/ノンラインマネージャー or スタッフ/医薬開発本部臨床薬理部
- 300428111
- 2026年10月05日更新
| 勤務地 | 兵庫県内 |
|---|---|
| 給与（年収） | 1400万円 応相談 |
| 募集科目 | 一般内科、小児科、その他（アレルギー科、免疫科）、製薬会社 |
| 交通アクセス | *** |
| 医療機関区分 | その他会社 |
| 病床数 | ・・・ |
| 屋内の受動喫煙対策 | 敷地内禁煙 |
求人情報
勤務内容・条件
| 募集科目 | 一般内科、小児科、その他（アレルギー科、免疫科）、製薬会社 |
|---|---|
| 勤務内容 | その他 対象科目：内科、小児科、アレルギー科、免疫科 Basic purpose of the job Senior CPhL-Asia supports the clinical development in Asia of new drugs and further development of approved drugs with emphasis on the design and execution of the Clinical Pharmacology (CP)development strategy. CPhL-Asia is accountable and responsible for communicating with regulatory authorities on CP topics and for CP aspects of drug submission in Asia (e.g., submission summaries). CPhL-Asia may act as trial clinical Pharmacologist (TCP; see TCP job profile) for clinical studies in their own project or outside of their own projects. CPhL-Asia may serve as Clin Pharm representative within various teams in Asia (Japan/China) in support of early integration of Japan/China into global development program. Post PoCP, they may serve as CP and TMCP representative in various Asian teams until submission and launch. CPhL-Asia will also serve as main TMCP representatives in all PMO projects in Asia. Accountabilities Ensure timely delivery of state-of-the-art Clinical Pharmacology scientific concepts for decision making throughout clinical drug development and registration in Asia including all necessary processes and documentation. Ensures timely delivery of state-of-the-art Clinical Pharmacology strategy development and implementation. Senior CPhL-Asia is responsible for defining the CP strategy (for instance, defining the drug-drug interaction liability or formulation development strategy for modified release) of assigned project. CPhL-Asia is also responsible for refining the CP strategy in a timely manner as new data become available during drug development. As part of the strategy, CPhL-Asia may define CP aspects in a clin trial protocol and for an eventual submission and further phase IV activities. Senior CPhL-Asia contributes to the Clin Pharm section of official documents (e.g., Information Brochure (IB), label); CPhL-Asia engages with regulatory agencies on matters pertaining to CP during drug development and are responsible for supporting Asian submission and post-submission activities with Clin Pharm and Biopharm expertise. Clinical development project representative Act as Clin Pharm representative in trial and project teams and regulatory meetings. CPhL-Asia serves as Clin Pharm representative within various teams in support of early integration of Japan/China into global development program. Post PoCP, they may serve as CP and TMCP representative in various Asian teams until submission and launch. CPhL-Asia may also serve as main TMCP representatives in all PMO projects in Asia. When delegating a trial to TCP, a CPhL-Asia is expected to ensure that adequate amount of information on the project and trial are provided to the TCP. For instance, a CPhL-Asia is expected to discuss study design and project standards with the TCP. A CPhL-Asia may function as a TCP in certain studies or projects. Driving science and innovation CPhL-Asia leads clinical development trial and project overarching topics from TMCP (e.g. by focus group). CPhL-Asia represents Clinical Pharmacology or TMCP in internal and external initiatives/working groups. CPhL-Asia continuously scouts, evaluates (incl piloting) and implements new methods and strategies in the area of Clinical Pharmacology. Strategic partnerships: CPhL-Asia implements collaborations and strategic partnerships with external bodies. They organize and manage projects with external organizations (e.g. CROs, ARO). CPhL-Asia may serve as subject matter expert (CP, Biopharm) in in –or outlicensing activities Functional processes: CPhL-Asia continuously develops and refines further functional processes and infrastructure. CPhL-Asia is CP (CP and Biopharm) experts and may offer this expertise to other interface functions (e.g, Toxicology, Pharmacovigilance, Customer Information, Marketing, Regulatory Affairs) or to support internal or external working groups. CPhL-Asia presents results internally and externally as well as contributes to scientific publications. Compliance (incl GCP): CPhL-Asia follows all ICH GCP, other relevant authority regulations and internal guidance to protect the rights, safety and wellbeing of trial subjects, including sample chain of custody, data privacy and data integrity. In addition, obligations outside the field of clinical studies, such as EHS, Pharmacovigilance, anti-corruption, BI-internal guidance should be followed. |
| 週勤務日数 | 5.0日 |
| 勤務時間 | (月～金) 08時45分 ～ 17時20分 ※配属先部門によりシフト勤務・フレックスタイム制の適用有り |
| 当直 | なし |
待遇・手当
| 給与（年俸） | 1400万円 応相談 |
|---|---|
| 赴任手当 | - |
| 住宅手当 | - |
| 宿舎の提供 | - |
| 自動車通勤 | - |
福利厚生
| 休日 | 日曜日、祝日、土曜日 |
|---|---|
| 休暇 | 年末年始、その他休暇、初年度有給休暇 |
| 研究日 | なし |
| 社会保険 | 健康保険、雇用保険、労災保険、厚生年金 |
| 学会出席 | - |
その他
| 試用期間 | あり（3カ月）同条件 |
|---|---|
| 備考 | 年 収：～1,400万円（スキル・経験による） 契約期間: 無期雇用 雇用形態: 正社員 試用期間: 有 期間〔3ヶ月〕 就業時間: 8：45～17：20（休憩45分） 配属先部門によりシフト勤務・フレックスタイム制の適用有り 時間外労働: 有 休日休暇: 年間休日131日（2025年度実績） 完全週休2日制（土日祝日）、年末年始、ゴールデンウイーク、お盆期間を中心に年3回程度の長期休日あり 初年度入社時有給休暇：10日 ※初年度は4/1入社時に10日分の年次有給休暇を付与します。 入社翌年以降は、毎年1/1付けで新たに年次有給休暇（2年目14日）を付与します。 半休および年次有給休暇の 1 時間単位の使用あり 積立休暇、慶弔休暇、リフレッシュ休暇、ボランティア休暇、看護等休暇等 福利厚生：企業年金制度、確定拠出年金制度、借上社宅制度、持家補助制度、団体長期障害所得補償保険、カフェテリアプラン（ベネフィットステーションを通じて会社からの年間付与ポイントを活用できます）等 給与改定: 年1回（4月） 賞与支給: 会社業績賞与（年1回） 加入保険: 健康保険 厚生年金保険 労災保険 雇用保険険 |
